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    <tradeName>08938532565495</tradeName>
    <deviceName>Disposable Surgical Gown</deviceName>
    <manufacturerName>SANQI (VIETNAM) NEW MATERIALS CO., LTD.</manufacturerName>
    <manufacturerSrn>VN-MF-000008919</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQ-G5001-XXL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:48:54.975Z</lastUpdated>
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    <udiDi>06974523673093</udiDi>
    <basicUdiDi>697452367A001ED</basicUdiDi>
    <tradeName>Standard Surgical Gown</tradeName>
    <deviceName>Surgical Gown</deviceName>
    <manufacturerName>S.E.S Healthcare products (Lingbi)  Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001143</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000385203</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:54:27.029Z</lastUpdated>
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    <udiDi>06974523671211</udiDi>
    <basicUdiDi>697452367A001ED</basicUdiDi>
    <tradeName>Standard Surgical Gown</tradeName>
    <deviceName></deviceName>
    <manufacturerName>S.E.S Healthcare products (Lingbi)  Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001143</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>434024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:41.392Z</lastUpdated>
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    <udiDi>06974523673109</udiDi>
    <basicUdiDi>697452367A001ED</basicUdiDi>
    <tradeName>Standard Surgical Gown</tradeName>
    <deviceName></deviceName>
    <manufacturerName>S.E.S Healthcare products (Lingbi)  Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001143</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000434024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:46:40.545Z</lastUpdated>
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    <udiDi>06931747862009</udiDi>
    <basicUdiDi>69317478SSG0000019C</basicUdiDi>
    <tradeName>Standard surgical gown XL</tradeName>
    <deviceName>Non-sterile Surgical Gowns</deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGXL01</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:55:56.283Z</lastUpdated>
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    <udiDi>16974436061335</udiDi>
    <basicUdiDi>697443606I00018B</basicUdiDi>
    <tradeName>Surgical gown</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiantao Zhongtai Protective Products Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008476</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCHTM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:29.744Z</lastUpdated>
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    <udiDi>16974436061342</udiDi>
    <basicUdiDi>697443606I00018B</basicUdiDi>
    <tradeName>Surgical gown</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiantao Zhongtai Protective Products Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008476</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCHTM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:29.015Z</lastUpdated>
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    <udiDi>16974436061328</udiDi>
    <basicUdiDi>697443606I00018B</basicUdiDi>
    <tradeName>Surgical gown</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiantao Zhongtai Protective Products Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008476</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCHTM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:27.596Z</lastUpdated>
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    <udiDi>09009607802100</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® HOOD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:28:00.286Z</lastUpdated>
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    <udiDi>09009607802209</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® TOGA SIZE XL_XXL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:28:00.269Z</lastUpdated>
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    <udiDi>09009607802216</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® TOGA SIZE M-L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:28:00.253Z</lastUpdated>
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    <udiDi>09009607802223</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® TOGA SIZE XXS-S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80222</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:28:00.232Z</lastUpdated>
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    <udiDi>09009607802308</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® PULL-OVER TOGA SIZE XL-XXL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:28:00.211Z</lastUpdated>
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    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® PULL-OVER TOGA SIZE M-L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80231</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.227Z</lastUpdated>
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    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® PULL-OVER TOGA SIZE XXS-S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.204Z</lastUpdated>
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    <udiDi>09009607803015</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® HOOD HFD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.181Z</lastUpdated>
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    <udiDi>09009607805002</udiDi>
    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® PEEL-OFF HOOD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.156Z</lastUpdated>
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    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® HOOD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80200V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.035Z</lastUpdated>
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    <tradeName>ViVi® TOGA SIZE XXL-XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80220V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.013Z</lastUpdated>
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    <basicUdiDi>9009607GOWNS80XXXD4</basicUdiDi>
    <tradeName>ViVi® TOGA SIZE M-L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80221V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.000Z</lastUpdated>
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